Voriconazol Hexal 200 mg, filmomhulde tabletten

البلد: هولندا

اللغة: الهولندية

المصدر: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

العنصر النشط:

VORICONAZOL

متاح من:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC رمز:

J02AC03

INN (الاسم الدولي):

VORICONAZOLE

الشكل الصيدلاني:

Filmomhulde tablet

تركيب:

CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171),

طريقة التعاطي:

Oraal gebruik

المجال العلاجي:

Voriconazole

ملخص المنتج:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POVIDON K 30 (E 1201); TITAANDIOXIDE (E 171);

تاريخ الترخيص:

2013-06-11

نشرة المعلومات

Sandoz B.V.
Page 1/13
Voriconazol Hexal 50 mg/200 mg, filmomhulde
tabletten
RVG 111737-8
V06
1.3.1.1 bijsluiter
maart 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VORICONAZOL HEXAL 50 MG, FILMOMHULDE TABLETTEN
VORICONAZOL HEXAL 200 MG, FILMOMHULDE TABLETTEN
voriconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET
1.
What [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Content of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] contains the active substance
voriconazole. [Nationally
completed name] is an antifungal medicine. It works by killing or
stopping the growth of the
fungi that cause infections.
It is used for the treatment of patients (adults and children over the
age of 2) with:
•
invasive aspergillosis (a type of fungal infection due to
_Aspergillus_
sp),
•
candidaemia (another type of fungal infection due to
_Candida_
sp) in non-neutropenic
patients (patients without abnormally low white blood cells count),
•
serious invasive
_Candida_
sp. infections when the fungus is resistant to fluconazole
(another antifungal medicine),
Sandoz B.V.
Page 2/13
Voriconazol Hexal 50 mg/200 mg, filmomhulde
tabletten
RVG 111737-8
V06
1.3.1.1 bijsluiter
maart 2020
•
serious fungal infections caused by
_Scedospo

خصائص المنتج

Sandoz B.V.
Page 1/39
Voriconazol Hexal 50 mg/200 mg, filmomhulde
tabletten
RVG 111737-8
V07
1.3.1.1 Samenvatting van de Productkenmerken
maart 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Voriconazol Hexal 50 mg, filmomhulde tabletten
Voriconazol Hexal 200 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg voriconazole.
Excipient with known effect
Each film-coated tablet contains 61,1 mg lactose (as monohydrate)
Each film-coated ablet contains 200 mg voriconazole.
Excipient with known effect
Each film-coated tablets contains 244.2 mg lactose (as monohydrat).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
50 mg, filmomhulde tabletten:
White to off-white, round, biconvex, film coated tablets with ‘50’
debossed on one side and
plain on other side.
Length: 7.1 ± 0.3 mm
Thickness 3.50 mm ± 0.30 mm
200 mg, filmomhulde tabletten:
White to off-white, biconvex, capsule shaped film coated tablets with
‘200’ debossed on one
side and plain on other side.
Length: 15.9 ± 0.3 mm
Thickness 6.20 mm ± 0.30 mm
Sandoz B.V.
Page 2/39
Voriconazol Hexal 50 mg/200 mg, filmomhulde
tabletten
RVG 111737-8
V07
1.3.1.1 Samenvatting van de Productkenmerken
maart 2020
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Voriconazole, is a broad spectrum, triazole antifungal agent and is
indicated in adults and
children aged 2 years and above as follows:
•
Treatment of invasive aspergillosis.
•
Treatment of candidaemia in non-neutropenic patients.
•
Treatment of fluconazole-resistant serious invasive
_Candida _
infections (including
_C. _
_krusei_
).
•
Treatment of serious fungal infections caused by
_Scedosporium _
spp. and
_Fusarium _
spp.
Voriconazol Hexal should be administered primarily to patients with
progressive, possibly
life-threatening infections.
Prophylaxis of invasive fungal infections in high risk allogeneic
hematopoietic stem cell
transplant (HSCT) recipients.
4.2 POSOLOGY AND ME